Gates Package — page 596

One of the biggest challenges to product development for infectious diseases is the cost of moving promising candidates through the pipeline. Recognizing this challenge, NIAID helps to provide the critical information necessary to advance products and lessen the fınancial risks associated with investing in product development. DMID offers a suite of preclinical services to conduct: • In vitro assessment for antimicrobial activity-- high-throughput and specifıc and broad spectrum screens to stimulate research towards discovery of improved antimicrobial therapies; • In vivo services (screening, effıcacy, development of animal models)-- the provision of a broad range of in vivo models, development of novel models, and refınement of existing models. Product screening and effıcacy testing for FDA submissions are also include; • Therapeutic development services-- preclinical services to support the development of products intended for use in the cure, mitigation, diagnosis, or treatment of disease caused by a pathogen or certain toxins; • Vaccine development services--resources to support the development of vaccines; vaccine components including adjuvants; vaccine delivery systems; other biologics; and biosafety lab (BSL)-2, BSL-3, and BSL-4 challenge material. Services include vaccine testing and vaccine manufacturing resources. DMID also provides resources to support: • Basic research to identify and develop targets. Services include repositories and 'omics resources; • Clinical evaluation resources to conduct and support clinical trials. DMID programs encompass a wide range of pathogens for nearly every human infectious agent spanning bacteria, viruses, parasites, fungi, toxins and vectors (DMID resources do not include those for HIV/AIDS). Services are provided by DMID-funded contractors and are offered free of charge.